134 research outputs found

    Current and Future Insights for Optimizing Antithrombotic Therapy to Reduce the Burden of Cardiovascular Ischemic Events in Patients with Acute Coronary Syndrome

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    The pharmacological treatment strategies for acute coronary syndrome (ACS) in recent years are constantly evolving to develop more potent antithrombotic agents, as reflected by the introduction of more novel P2Y12 receptor inhibitors and anticoagulants to reduce the ischemic risk among ACS patients. Despite the substantial improvements in the current antithrombotic regimen, a noticeable number of ACS patients continue to experience ischemic events. Providing effective ischemic risk reduction while balancing bleeding risk remains a clinical challenge. This updated review discusses the currently approved and widely used antithrombotic agents and explores newer antithrombotic treatment strategies under development for the initial phase of ACS

    Contralateral hip fractures and other osteoporosis-related fractures in hip fracture patients: Incidence and risk factors. An observational cohort study of 1,229 patients

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    Purpose: To report risk factors, 1-year and overall risk for a contralateral hip and other osteoporosis-related fractures in a hip fracture population. Methods: An observational study on 1,229 consecutive patients of 50 years and older, who sustained a hip fracture between January 2005 and June 2009. Fractures were scored retrospectively for 2005-2008 and prospectively for 2008-2009. Rates of a contralateral hip and other osteoporosis- related fractures were compared between patients with and without a history of a fracture. Previous fractures, gender, age and ASA classification were analysed as possible risk factors. Results: The absolute risk for a contralateral hip fracture was 13.8 %, for one or more osteoporosis-related fracture( s) 28.6 %. First-, second- and third-year risk for a second hip fracture was 2, 1 and 0 %. Median (IQR) interval between both hip fractures was 18.5 (26.6) months. One-year incidence of other fractures was 6 %. Only age was a risk factor for a contralateral hip fracture, hazard ratio (HR) 1.02 (1.006-1.042, p = 0.008). Patients with a history of a fracture (33.1 %) did not have a higher incidence of fractures during follow-up (16.7 %) than patients without fractures in their history (14 %). HR for a contralateral hip fracture for the fracture versus the non-fracture group was 1.29 (0.75-2.23, p = 0.360). Conclusion: The absolute risk of a contralateral hip fracture after a hip fracture is 13.8 %, the 1-year risk was 2 %, with a short interval between the 2 hip fractures. Age was a risk factor for sustaining a contralateral hip fracture; a fracture in history was not

    Surgical outcomes in surgical oncology patients who participated in a family involvement program

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    BACKGROUND: There is a lack of evidence regarding the relationship between family involvement and outcomes in gastrointestinal oncology patients after surgery. To evaluate the effect of a family involvement program for patients undergoing oncologic gastrointestinal surgery on unplanned readmissions within 30 days after surgery.METHODS: A multicenter patient-preference cohort study compared 2 groups: patients who participated in the family involvement program versus usual care. The program comprised involvement of family caregivers in care and training of health care professionals in family-centered care. Multivariable regression analyses were used to evaluate the effect of the FIP on the number of unplanned readmissions up to 30 days after surgery. Secondary outcomes included complications sensitive to fundamental care activities, emergency department visits, intensive care unit admissions, hospital length of stay, and the need for professional home care after discharge.RESULTS: Of the 301 patients included, 152 chose the family involvement program, and 149 chose usual care. Postoperative readmissions occurred in 25 (16.4%) patients in the family involvement program group, and 15 (10.1%) in the usual care group (P = .11). A significant reduction of 16.2% was observed in the need for professional home care after discharge in the family involvement program group (P &lt; .01). No significant differences were found between the 2 groups in the other secondary outcomes.CONCLUSION: The family involvement program did not reduce the number of unplanned readmissions, but it led to a substantial reduction in-home care, which suggests an economic benefit from a societal perspective. Implementation of the family involvement program should, therefore, be considered in clinical practice.</p

    Surgical outcomes in surgical oncology patients who participated in a family involvement program

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    BACKGROUND: There is a lack of evidence regarding the relationship between family involvement and outcomes in gastrointestinal oncology patients after surgery. To evaluate the effect of a family involvement program for patients undergoing oncologic gastrointestinal surgery on unplanned readmissions within 30 days after surgery.METHODS: A multicenter patient-preference cohort study compared 2 groups: patients who participated in the family involvement program versus usual care. The program comprised involvement of family caregivers in care and training of health care professionals in family-centered care. Multivariable regression analyses were used to evaluate the effect of the FIP on the number of unplanned readmissions up to 30 days after surgery. Secondary outcomes included complications sensitive to fundamental care activities, emergency department visits, intensive care unit admissions, hospital length of stay, and the need for professional home care after discharge.RESULTS: Of the 301 patients included, 152 chose the family involvement program, and 149 chose usual care. Postoperative readmissions occurred in 25 (16.4%) patients in the family involvement program group, and 15 (10.1%) in the usual care group (P = .11). A significant reduction of 16.2% was observed in the need for professional home care after discharge in the family involvement program group (P &lt; .01). No significant differences were found between the 2 groups in the other secondary outcomes.CONCLUSION: The family involvement program did not reduce the number of unplanned readmissions, but it led to a substantial reduction in-home care, which suggests an economic benefit from a societal perspective. Implementation of the family involvement program should, therefore, be considered in clinical practice.</p

    ULTrasound-guided TRAnsfemoral puncture in COmplex Large bORe PCI: study protocol of the UltraCOLOR trial

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    Introduction Although recently published evidence favours transradial access (TRA) when using large-bore guiding catheters for percutaneous coronary intervention (PCI) of complex coronary lesions, the femoral artery will still be used in a considerate proportion of patients undergoing complex PCI, especially in PCI of chronic total occlusions (CTO). Ultrasound-guided puncture of the femoral artery may reduce clinically relevant access site complications, but robust evidence is lacking up to date. Methods and analysis A total of 542 patients undergoing complex PCI, defined as PCI of CTO, complex bifurcation, heavy calcified lesion or left main, in which the 7-F or 8-F transfemoral access is required, will be randomised to ultrasound-guided puncture or fluoroscopy-guided puncture. The primary outcome is the incidence of the composite end-point of clinically relevant access site related bleeding and/or vascular complications requiring intervention. Access site complications and major adverse cardiovascular events up to 1 month will also be compared between both groups. Ethics and dissemination Ethical approval for the study was granted by the local Ethics Committee ('Medisch Ethische Toetsing Commissie Isala Zwolle') for all Dutch sites, 'Comité Medische Ethiek Ziekenhuis Oost-Limburg' for Hospital Oost-Limburg, 'Comité d'éthique CHU-Charleroi - ISPPC' for Centre Hospilatier Universitaire de Charleroi and 'Ethik Kommission de Arztekammer Nordrhein' for Elisabeth-Krankenhaus). The trial outcomes will be published in peer-reviewed journals of the concerned literature. The ultrasound guided transfemoral access in complex large bore PCI trial has been administered in the ClinicalTrials.gov database, reference number: NCT03846752. Registration details ClinicalTrials.gov identifier: NCT03846752

    Safety and effectiveness of the early-onset sepsis calculator to reduce antibiotic exposure in at-risk newborns:a cluster-randomised controlled trial

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    Background: Newborns are at risk for early-onset sepsis (EOS), occurring 0.2–2.0 per 1000 live births, and for antibiotic overtreatment: approximately 5–15% receive antibiotics for suspected EOS under conventional guidelines with categorical risk factor assessment. Use of the multivariate neonatal EOS calculator prediction tool can reduce overtreatment, but no trials have been conducted to compare its safety to these categorical guidelines. Methods: Between April 12th, 2022, and March 19th, 2024, we conducted an open-label, two-armed, cluster-randomised controlled trial among newborns born at ≥34 weeks’ gestational age with ≥1 EOS risk factor, comparing 10 hospitals randomised 1:1 to EOS calculator use versus categorical guideline use (ClinicalTrials.gov number: NCT05274776). The EOS calculator was slightly adapted for Dutch use. The co-primary non-inferiority outcome assessed safety using four predefined harm criteria (respiratory support, circulatory support, referral to intensive care unit, and culture-confirmed EOS). Non-inferiority was established if the upper limit of the 95% confidence interval (CI) for the relative risk did not exceed 1.5. The co-primary superiority outcome assessed the reduction of participants starting antibiotic therapy for suspected EOS within 24 h postpartum. Secondary endpoints were the duration of antibiotic therapy and the initiation of antibiotic therapy between 24 and 72 h after birth. Intention-to-treat and per-protocol analyses were performed. Findings:1830 newborns (183 per cluster) were included. At least one harm criterion was present in 64 (7.0%) of 915 in the EOS calculator arm and 134 (14.6%) of 915 in the categorical guideline arm (relative risk 0.48; 95% Cl 0.36–0.63). Antibiotics for suspected EOS were started in 66 (7.2%) of 915 in the EOS calculator arm, compared with 243 (26.6%) of 915 in the categorical guideline arm (absolute risk reduction: 19.0%, 95% CI 11.3–26.7). Median duration of antibiotics was longer in the EOS calculator arm (5.5 days, IQR 1.8–6.6) than in the categorical guideline arm (2.1 days, IQR 1.6–6.3) (P 0.0019). We found no difference in the proportion of newborns started on antibiotic therapy for suspected EOS between 24 and 72 h after birth. Adverse event rates were similar between arms. Readmission for suspected early-onset sepsis occurred three times in the EOS calculator and two times in the categorical guideline arm. Any cultures obtained at readmission remained negative, and any symptoms resolved completely.Interpretation: These trial data support safety and effectiveness of the EOS calculator for harm criteria and for the proportion of participants that started antibiotic therapy. Funding: This study was supported by SPIN, the General Paediatrics Research Network of the Dutch Association for Paediatrics, supported by het Cultuurfonds.</p

    Development and Internal Validation of a Novel Nomogram Predicting the Outcome of Salvage Radiation Therapy for Biochemical Recurrence after Radical Prostatectomy in Patients without Metastases on Restaging Prostate-specific Membrane Antigen Positron Emission Tomography/Computed Tomography

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    BACKGROUND AND OBJECTIVE: Owing to the greater use of prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) in patients with biochemical recurrence (BCR) of prostate cancer (PCa) after robot-assisted radical prostatectomy (RARP), patient selection for local salvage radiation therapy (sRT) has changed. Our objective was to determine the short-term efficacy of sRT in patients with BCR after RARP, and to develop a novel nomogram predicting BCR-free survival after sRT in a nationwide contemporary cohort of patients who underwent PSMA PET/CT before sRT for BCR of PCa, without evidence of metastatic disease.METHODS: All 302 eligible patients undergoing PCa sRT in four reference centers between September 2015 and August 2020 were included. We conducted multivariable logistic regression analysis using a backward elimination procedure to develop a nomogram for predicting biochemical progression of PCa, defined as prostate-specific antigen (PSA) ≥0.2 ng/ml above the post-sRT nadir within 1 yr after sRT.KEY FINDINGS AND LIMITATIONS: Biochemical progression of disease within 1 yr after sRT was observed for 56/302 (19%) of the study patients. The final predictive model included PSA at sRT initiation, pathological grade group, surgical margin status, PSA doubling time, presence of local recurrence on PSMA PET/CT, and the presence of biochemical persistence (first PSA result ≥0.1 ng/ml) after RARP. The area under the receiver operating characteristic curve for this model was 0.72 (95% confidence interval 0.64-0.79). Using our nomogram, patients with a predicted risk of &gt;20% had a 30.8% chance of developing biochemical progression within 1 yr after sRT.CONCLUSIONS: Our novel nomogram may facilitate better patient counseling regarding early oncological outcome after sRT. Patients with high risk of biochemical progression may be candidates for more extensive treatment.PATIENT SUMMARY: We developed a new tool for predicting cancer control outcomes of radiotherapy for patients with recurrence of prostate cancer after surgical removal of their prostate. This tool may help in better counseling of these patients with recurrent cancer regarding their early expected outcome after radiotherapy.</p

    Development and Internal Validation of a Novel Nomogram Predicting the Outcome of Salvage Radiation Therapy for Biochemical Recurrence after Radical Prostatectomy in Patients without Metastases on Restaging Prostate-specific Membrane Antigen Positron Emission Tomography/Computed Tomography

    Get PDF
    BACKGROUND AND OBJECTIVE: Owing to the greater use of prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) in patients with biochemical recurrence (BCR) of prostate cancer (PCa) after robot-assisted radical prostatectomy (RARP), patient selection for local salvage radiation therapy (sRT) has changed. Our objective was to determine the short-term efficacy of sRT in patients with BCR after RARP, and to develop a novel nomogram predicting BCR-free survival after sRT in a nationwide contemporary cohort of patients who underwent PSMA PET/CT before sRT for BCR of PCa, without evidence of metastatic disease.METHODS: All 302 eligible patients undergoing PCa sRT in four reference centers between September 2015 and August 2020 were included. We conducted multivariable logistic regression analysis using a backward elimination procedure to develop a nomogram for predicting biochemical progression of PCa, defined as prostate-specific antigen (PSA) ≥0.2 ng/ml above the post-sRT nadir within 1 yr after sRT.KEY FINDINGS AND LIMITATIONS: Biochemical progression of disease within 1 yr after sRT was observed for 56/302 (19%) of the study patients. The final predictive model included PSA at sRT initiation, pathological grade group, surgical margin status, PSA doubling time, presence of local recurrence on PSMA PET/CT, and the presence of biochemical persistence (first PSA result ≥0.1 ng/ml) after RARP. The area under the receiver operating characteristic curve for this model was 0.72 (95% confidence interval 0.64-0.79). Using our nomogram, patients with a predicted risk of &gt;20% had a 30.8% chance of developing biochemical progression within 1 yr after sRT.CONCLUSIONS: Our novel nomogram may facilitate better patient counseling regarding early oncological outcome after sRT. Patients with high risk of biochemical progression may be candidates for more extensive treatment.PATIENT SUMMARY: We developed a new tool for predicting cancer control outcomes of radiotherapy for patients with recurrence of prostate cancer after surgical removal of their prostate. This tool may help in better counseling of these patients with recurrent cancer regarding their early expected outcome after radiotherapy.</p
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